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Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin

30 oktober 2026 bijgewerkt door: Anna Krentowska, Medical University of Bialystok

Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin - the Association With Metabolic Control of Diabetes and Markers of Early Vascular Changes

The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin. Additionally, the study aims to assess the association between metabolic control of diabetes and markers of early cardiovascular disease, taking into account the impact of CGM use.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Pharmacological treatment of type 2 diabetes (T2DM) has advanced significantly in recent years. However, despite increasing availability of new medications, a great proportion of patients do not achieve treatment goals, which leads to an increased risk of chronic complications. Continuous glucose monitoring (CGM) systems have become standard of care in persons with diabetes treated with insulin, although they might also be a useful tool in guiding behaviour and dietary choices in patients treated with non-insulin medications. However, the data on their potential benefits in people with T2DM not using insulin are scarce. Therefore, the study aims to investigate the influence of CGM use on metabolic control and quality of life in this group of patients.

The study subjects will be randomly assigned to one of two groups: using continuous glucose monitoring systems or performing self-monitoring of blood glucose with a glucose meter. The intervention time will be 12 weeks, with control visits every 4 weeks. A post-intervention follow-up visit to assess whether the achieved results are maintained will be performed at 3 months after completing the intervention.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Polen
      • Bialystok, Polen, 15-276
        • Werving
        • Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases
        • Contact:
        • Hoofdonderzoeker:
          • Anna Krentowska, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age between 18 and 65 years (both inclusive)
  • Type 2 diabetes diagnosed at least 6 months prior to entering the study
  • Body mass index ≥25 kg/m2
  • Diabetes treated with oral medications and/or GLP-1 receptor agonists and/or tirzepatide
  • No modifications of diabetes treatment in the previous 3 months
  • HbA1c between 7.5% and 10% (both inclusive)
  • Oral and written informed consent for participation

Exclusion Criteria:

  • Type 1 diabetes, gestational diabetes, other specific types of diabetes
  • HbA1c >10.0%
  • Treatment with insulin
  • Previous use of any continuous glucose monitoring system
  • GFR <30 ml/min
  • Acute infections, acute diabetes complications and/or unplanned hospitalisations in the previous month
  • Use of steroids or immunosuppressive medications in the previous 3 months
  • Chemotherapy, radiotherapy, immune therapy in the previous 3 months
  • Pregnancy and/or breastfeeding
  • Skin lesions or dermatological conditions preventing proper sensor insertion
  • Cognitive impairment and/or other conditions preventing proper use of continuous glucose monitoring system
  • Lack of consent for the use of continuous glucose monitoring system

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Continuous glucose monitoring

Dexcom One+ continuous glucose monitoring system
Apparaat: Continuous glucose monitoring

Participants will be randomized to use Dexcom One+ continuous glucose monitoring system for 12 weeks, with control visits every four weeks.
Ander: Self-monitoring of blood glucose
Apparaat: Self-monitoring of blood glucose

Participants will be randomized to continue self-monitoring of blood glucose with a glucose meter as per usual practice, with control visits every four weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in time in range
Tijdsspanne: Week 12

Observed change in time in range (70-180 mg/dl) from baseline to week 12 in the group using CGM system compared to the group using SMBG.
Week 12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HbA1c
Tijdsspanne: Week 12

Observed change in the percentage of glycated haemoglobin (HbA1c) from baseline to week 12.
Week 12
Change in TITR
Tijdsspanne: Week 12

Observed change in time in tight range (TITR; 70-140 mg/dl) from baseline to week 12.
Week 12
Change in TAR
Tijdsspanne: Week 12

Observed change in time above range (TAR; >180 mg/dl) from baseline to week 12.
Week 12
Change in TBR
Tijdsspanne: Week 12

Observed change in time below range (TBR; <70 mg/dl) from baseline to week 12.
Week 12
Change in CV
Tijdsspanne: Week 12

Observed change in glycaemic variability assessed with coefficient of variation (CV) from baseline to week 12.
Week 12
Change in body weight (kg)
Tijdsspanne: Week 12

Observed change in body weight from baseline to week 12.
Week 12
Change in markers of early vascular disease
Tijdsspanne: Week 12

Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from baseline to week 12.
Week 12
Change in diabetes distress: DDS
Tijdsspanne: Week 12

Observed change in diabetes distress measured with DDS questionnaire from baseline to week 12.

DDS is a 17-item questionnaire assessing diabetes distress over the previous month. Scores <2 points indicates no/little distress, 2-2.9 points - moderate distress, and ≥3 points - high distress.
Week 12
Change in PHQ-9
Tijdsspanne: Week 12

Observed change in Patient Health Questionnaire-9 (PHQ-9) score from baseline to week 12.

PHQ-9 is a 9-item questionnaire for screening, diagnosing, monitoring and measuring the severity of depression. Total score: 0-27 points; higher scores reflect greater severity of depressive symptoms.
Week 12
Change in quality of life: WHOQOL-BREF questionnaire
Tijdsspanne: Week 12

Observed change in abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire from baseline to week 12.

Total score: 0-100 points; higher scores reflect higher quality of life.
Week 12
Change in sleep quality: PSQI
Tijdsspanne: Week 12

Observed change in sleep quality measured with Pittsburgh Sleep Quality Index (PSQI) from baseline to week 12.

Total score: 0-21 points; a score greater than 5 indicates significant sleep difficulties.
Week 12
Change in TIR after completing the intervention
Tijdsspanne: Week 24

Observed change in time in range (TIR; 70-180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in HbA1c after completing the intervention
Tijdsspanne: Week 24

Observed change in the percentage of glycated haemoglobin (HbA1c) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in TITR after completing the intervention
Tijdsspanne: Week 24

Observed change in time in tight range (TITR; 70-140 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in TAR after completing the intervention
Tijdsspanne: Week 24

Observed change in time above range (TAR; >180 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in TBR after completing the intervention
Tijdsspanne: Week 24

Observed change in time below range (TBR; <70 mg/dl) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in CV after completing the intervention
Tijdsspanne: Week 24

Observed change in glycaemic variability assessed with coefficient of variation (CV) from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24
Change in markers of early vascular disease after completing the intervention
Tijdsspanne: Week 24

Observed change in the concentrations of circulating markers of subclinical vascular disease: oxLDL, VCAM-1, ICAM-1, E-selectin, interleukin 6, interleukin 18 from week 12 (end of intervention) to week 24 (post-intervention follow-up).
Week 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medical University of Bialystok

Medewerkers

Diabetes Poland

Onderzoekers

  • Hoofdonderzoeker: Anna Krentowska, MD, PhD, Medical University of Bialystok

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2026

Eerst geplaatst (Werkelijk)

5 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • APK.002.300.2025

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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